A Study of MF101 in Postmenopausal Women (HERBA)

February 6, 2012 updated by: Bionovo

A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.

MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jesse Langon, MPH
  • Phone Number: 510-4204182

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Recruiting
        • Arizona Research Center
      • Tucson, Arizona, United States
        • Recruiting
        • Visions Clinical Research Center
    • California
      • Berkeley, California, United States
        • Recruiting
        • Alta Bates Summit Medical Center
      • Sacramento, California, United States
        • Recruiting
        • Northern California Research
      • San Diego, California, United States
        • Not yet recruiting
        • Genesis Center for Clinical Research
      • San Diego, California, United States
        • Recruiting
        • Medical Center for Clinical Research
    • Colorado
      • Denver, Colorado, United States
        • Recruiting
        • Downtown Women's Health Care
    • Florida
      • Boynton Beach, Florida, United States
        • Recruiting
        • Visions Clinical Research
      • Bradenton, Florida, United States
        • Recruiting
        • Meridien Research
      • Brooksville, Florida, United States
        • Recruiting
        • Meridien Research
      • New Port Richey, Florida, United States
        • Recruiting
        • Suncoast Clinical Research
      • Orlando, Florida, United States
        • Recruiting
        • Compass Research
      • Palm Harbor, Florida, United States
        • Recruiting
        • Suncoast Clinical Research
      • St. Petersburg, Florida, United States
        • Recruiting
        • Meridien Research
      • Tampa, Florida, United States
        • Recruiting
        • Meridien Research
      • West Palm Beach, Florida, United States
        • Recruiting
        • OB/GYN Specialists of the Palm Beaches
    • Georgia
      • Decatur, Georgia, United States
        • Recruiting
        • Soapstone Center for Clinical Research
      • Sandy Springs, Georgia, United States
        • Recruiting
        • Mount Vernon Clinical Research
    • Idaho
      • Boise, Idaho, United States
        • Recruiting
        • Advanced Clinical Research
    • Maryland
      • Baltimore, Maryland, United States
        • Not yet recruiting
        • Johns Hopkins University
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Not yet recruiting
        • Tufts University
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Not yet recruiting
        • Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Recruiting
        • Albuquerque Clinical Trials
      • Albuquerque, New Mexico, United States
        • Recruiting
        • New Mexico Clinical Research & Osteoporosis Center
    • New York
      • Rochester, New York, United States
        • Recruiting
        • Rochester Clinical Research
    • North Carolina
      • New Bern, North Carolina, United States
        • Recruiting
        • Eastern Carolina Women's Center
      • Raleigh, North Carolina, United States
        • Recruiting
        • PMG Research
      • Winston-Salem, North Carolina, United States
        • Recruiting
        • Hawthorne Medical Research
    • Ohio
      • Cleveland, Ohio, United States
        • Recruiting
        • Rapid Medical Research
      • Columbus, Ohio, United States
        • Recruiting
        • Columbus Center for Women's Health Research
    • Oregon
      • Eugene, Oregon, United States
        • Recruiting
        • Clinical Trials Of America
      • Medford, Oregon, United States
        • Recruiting
        • Advanced Clinical Research - A Division of Medford Women's Clinic
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
        • Recruiting
        • The Clinical Trial Center
      • Philadelphia, Pennsylvania, United States
        • Recruiting
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Recruiting
        • University of Pittsburgh
    • South Carolina
      • Columbia, South Carolina, United States
        • Recruiting
        • South Carolina Clinical Research
      • Mt. Pleasant, South Carolina, United States
        • Recruiting
        • Coastal Carolina Research Center
    • Tennessee
      • Franklin, Tennessee, United States
        • Recruiting
        • HCCA - Clinical Research Solutions
      • Jackson, Tennessee, United States
        • Recruiting
        • HCCA - Clinical Research Solutions
      • Memphis, Tennessee, United States
        • Not yet recruiting
        • University of Tennessee at Memphis
      • Smyrna, Tennessee, United States
        • Recruiting
        • HCCA - Clinical Research Solutions
    • Texas
      • Austin, Texas, United States
        • Recruiting
        • Benchmark Research
      • Austin, Texas, United States
        • Recruiting
        • Women Partners in Health/Professional Quality Research
      • Dallas, Texas, United States
        • Recruiting
        • Discovery Clinical Trials
      • Lake Jackson, Texas, United States
        • Recruiting
        • R/D Clinical Research
    • Utah
      • West Jordan, Utah, United States
        • Recruiting
        • Advanced Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States
        • Recruiting
        • University of Virginia
      • Norfolk, Virginia, United States
        • Recruiting
        • National Clinical Research
      • Richmond, Virginia, United States
        • Recruiting
        • National Clinical Research Center
    • Washington
      • Seattle, Washington, United States
        • Recruiting
        • Seattle Women's Health, Research and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria (limited):

  • Confirmed postmenopausal women aged 40-65
  • Provide written informed consent

Exclusion Criteria (limited):

  • History of malignancy, with the exception of certain types of skin cancer or cervical cancer
  • Known carrier of BRCA1 or BRCA2
  • Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
  • Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
  • Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
  • History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
  • Active liver disease or gall bladder disease
  • History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
  • Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
  • Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
  • Chronic use of morphine or other opiates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
Experimental: MF101 5 g/day
Drug: MF101 5 g/day
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
Experimental: MF101 10 g/day
Drug: MF101 10 g/day
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.
Time Frame: 12 weeks
Safety will be measured through clinically significant findings in physical examinations, laboratory parameters, endometrial changes, abnormal uterine bleeding and any other adverse events. Efficacy will be measured by the mean change in frequency of moderate to severe hot flushes from baseline to treatment week 12.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionovo

Investigators

  • Study Director: Mary Tagliaferri, M.D, L.Ac., Bionovo Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF-101-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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